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ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults
Efficacy results from a randomized trial
Liles, E. G., Leo, M. C., Freed, A. S., Porter, K. M., Zepp, J. M., Kauffman, T. L., Keast, E., McMullen, C. K., Gruß, I., Biesecker, B. B., Muessig, K. R., Eubanks, D. J., Amendola, L. M., Dorschner, M. O., Rolf, B. A., Jarvik, G. P., Goddard, K. A. B., & Wilfond, B. S. (2022). ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial. Genetics in Medicine, 24(8), 1664-1674. https://doi.org/10.1016/j.gim.2022.04.008
PURPOSE: Individuals having genomic sequencing can choose to be notified about pathogenic variants in genes unrelated to the testing indication. A decision aid can facilitate weighing one's values before making a choice about these additional results.
METHODS: We conducted a randomized trial (N = 231) comparing informed values-choice congruence among adults at risk for a hereditary cancer syndrome who viewed either the Optional Results Choice Aid (ORCA) or web-based additional findings information alone. ORCA is values-focused with a low-literacy design.
RESULTS: Individuals in both arms had informed values-choice congruence (75% and 73% in the decision aid and web-based groups, respectively; odds ratio [OR] = 1.10, 95% CI = 0.58-2.08). Most participants had adequate knowledge (79% and 76% in the decision aid and web-based groups, respectively; OR = 1.20, 95% CI = 0.61-2.34), with no significant difference between groups. Most had information-seeking values (97% and 98% in the decision aid and web-based groups, respectively; OR = 0.59, 95% CI = 0.10-3.61) and chose to receive additional findings.
CONCLUSION: The ORCA decision aid did not significantly improve informed values-choice congruence over web-based information in this cohort of adults deciding about genomic results. Both web-based approaches may be effective for adults to decide about receiving medically actionable additional results.